The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Chlorpheniramine Maleate 4 Mg (NDC 71335-0963). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, warnings, otc - ask doctor/pharmacist, general precautions, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Chlorpheniramine maleate 4 mg
Antihistamine
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
Drug Facts continued on back of label
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years and over | take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours |
| children 6 years to under 12 years | take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours |
| children under 6 years | do not use |
croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
Product: 71335-0963
NDC: 71335-0963-1 30 TABLET in a BOTTLE
NDC: 71335-0963-2 60 TABLET in a BOTTLE
NDC: 71335-0963-3 100 TABLET in a BOTTLE
NDC: 71335-0963-4 120 TABLET in a BOTTLE
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